U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
On 3/7/2017, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Action To Be Taken:
1. Examine inventory immediately to determine if you have affected products and quarantine affected products.
2. Return the affected products to Cook Medical with a copy of the Acknowledgement and Receipt Form to
receive a product credit.
3. Even if you do not have affected products on hand, you must still complete the Acknowledgement and
Receipt Form and send it via fax (812.339.7316) or email to (fieldactionsna@cookmedical.com).
4. Complete and return the Acknowledgement and Receipt Form attached to this letter within 30 days.
5. Report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235,
Monday through Friday between 7:30 am and 5:00 pm (Eastern time), or by email via
customerrelationsna@cookmedical.com.
This notice must be shared with appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred.
Should you have any questions or concerns, please contact Cook Medical
Customer Relations at 800.457.4500 or 812.339.2235.
The devices have been distributed within the United States and the following countries: Bahamas, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Ireland, Israel, Italy, Jersey, Kuwait, Mexico, Morocco, New Zealand, Norway, Panama, Paraguay, Portugal, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Trinidad and Tobago, United Arab Emirates and the United Kingdom.
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